FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spartan SC 069
K Number: K220716
·
Decision May 5, 2022
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
3
Review Days
55
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Basic Information
- Device Name
- Spartan SC 069
- K Number
- K220716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spartan Micro, Inc.
- Date Received
- March 11, 2022
- Decision Date
- May 5, 2022
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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